The Medicines and Healthcare Products Regulatory Agency (MHRA) of United Kingdom has posted a medical device safety alert concerning EndoBarrier Gastrointestinal Liner System, Packaged, Sterile US [Part Number: 40-10-00624], manufactured by GI Dynamics (GID).
Due to the incidence rate of hepatic abscess (HA) in the United States (US) Investigational Device Exemption ENDO Trial exceeding the established safety threshold of 2%, the study was terminated by GID prior to completion.
The manufacturer and the US Food and Drug Administration (FDA) have come to a mutual agreement to conclude the ENDO trial as of 30 July 2015. With seven cases of hepatic abscess in the ENDO Trial, the incidence rate is approximately 3.5%, which exceeds a previously established safety threshold of 2%.
The overall historical rate of hepatic abscess in markets outside the US is approximately 0.94% based on experience with approximately 3,200 units shipped commercially since 2009. This rate reflects an increase from 0.49% observed globally two years ago, but is still low and below the 2% threshold established for the treatment. All reported cases of HA that developed after EndoBarrier implantation have been fully resolved upon device removal.
The manufacturer will immediately begin explanting the device from all remaining ENDO Trial participants and closing out the ENDO Trial. The manufacturer expects to complete all explants by the end of October. EndoBarrier will continue to be available to patients who need it in all countries around the world where it is approved for commercial use.
Physicians are advised to continue to educate patients on the early signs of HA (e.g., right upper quadrant pain, abdominal pain, fever/chills/malaise) and remind them to seek immediate treatment and resolution to mitigate any complications should they be present.
For details, please refer to the MHRA website:
https://www.gov.uk/government/publications/safety-information-from-manufacturers-field-safety-notices/field-safety-notices-28-september-to-2-october-2015
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 6 October 2015